K191364 is an FDA 510(k) clearance for the T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01. This device is classified as a System, Automated Platelet Aggregation (Class II - Special Controls, product code JOZ).
Submitted by Fujimori Kogyo, Co., Ltd. (Shinjuku, Tokyo, JP). The FDA issued a Cleared decision on February 14, 2020, 268 days after receiving the submission on May 22, 2019.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5700.
| 510(k) Number | K191364 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2019 |
| Decision Date | February 14, 2020 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JOZ - System, Automated Platelet Aggregation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5700 |